DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 and 2/26/2026 has been entered.
Response to Amendment
The Amendment filed on 2/3/2026 and 2/26/2026 has been entered. Claims 1-4, 6 and 11 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the final Office Action mailed 12/3/2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malkin, H, “An Ultramicro Protein-Bound Iodine Method on Capillary Blood” The Journal of Clinical Endocrinology & Metabolism, January 1965, Volume 25, Issue 1, Pages 28–38, hereinafter Malkin.
Regarding claim 1, Malkin teaches a kit (page 30, column 1) for preparing a diluted blood sample for measuring free steroids in blood (intended use MPEP § 2114 (II)), comprising: (a) a zinc sulfate (ZnSO4) solution (page 30, column 1, step 2b) configured to precipitate proteins from a blood sample obtained from a subject (intended use MPEP § 2114 (II) and is taught in page 30, column 1, step 2e); and (b) a potassium carbonate (KCO3) solution (page 30, column 1, step 3a) configured to inactivate zinc ions present in a supernatant obtained after protein precipitation (intended use MPEP § 2114 (II)), wherein the kit is configured such that the zinc sulfate solution is added to the blood sample prior to the potassium carbonate solution (intended use MPEP § 2114 (II) and is taught in page 30, column 1, steps 2-3), and wherein, after addition of potassium carbonated solution, the blood sample is centrifuged to obtain a supernatant, and a concentration of steroid contained in the obtained supernatant is measured (intended use MPEP § 2114 (II)).
Regarding claim 2, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Malkin and the apparatus of Malkin is capable of having the free steroids comprise all steroid hormones present in free form. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Malkin (see MPEP §2114).
Regarding claim 3, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Malkin and the apparatus of Malkin is capable of having the steroid hormones comprise cortisol. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Malkin (see MPEP §2114).
Regarding claim 4, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Malkin and the apparatus of Malkin is capable of having the blood sample be whole blood, serum or plasma. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Malkin (see MPEP §2114). Further, this limitation is taught in page 251, column 2, paragraph 7.
Regarding claim 6, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Malkin and the apparatus of Malkin is capable of adding 1 to 2 mL of 1 to 125 mM zinc sulfate solution per 1 mL of blood sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Malkin (see MPEP §2114).
Regarding claim 11, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Malkin and the apparatus of Malkin is capable of having concentration of steroids contained in the obtained supernatant measured by an enzyme immunoreaction method or mass spectrometry. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Malkin (see MPEP §2114).
Response to Arguments
Applicant's arguments filed 2/26/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Malkin teaches discarding supernatant after precipitation and therefore cannot measure free steroids as they are located in the supernatant, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim is directed to a kit and therefore, the processes which are utilized with the materials found in the kit claim have minimal patentable weight and only need to be capable of being utilized in the manner described and the zinc sulfate and potassium carbonate recited in Malkin would be able to be used in the manner described.
In response to applicant's argument that Malkin teaches using potassium carbonate to ensure a carbon free ash during high temperature digestion and not used for the chemical inactivation of zinc ions in the liquid phase, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim is directed to a kit and therefore, the processes which are utilized with the materials found in the kit claim have minimal patentable weight and only need to be capable of being utilized in the manner described and the potassium carbonate recited in Malkin would be able to be used in the manner described.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the method of Malkin is destructive and the applicant’s method is not) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, in response to applicant's argument that Malkin teaches using a destructive analysis and the applicant’s method is not destructive, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim is directed to a kit and therefore, the processes which are utilized with the materials found in the kit claim have minimal patentable weight and only need to be capable of being utilized in the manner described and the zinc sulfate and potassium carbonate recited in Malkin would be able to be used in the manner described.
Regarding applicant’s argument regarding the superior recovery of free steroids is not found persuasive. The claim is directed at a kit and not at a method claim. Therefore, the processes which are utilized with the materials found in the kit claim have minimal patentable weight and only need to be capable of being utilized in the manner described and the zinc sulfate and potassium carbonate recited in Malkin would be able to be used in the manner described to achieve a superior recovery of free steroids.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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